1. Field of the Invention
The present invention relates generally to natural, anhydrous oral care compositions suitable for topical application for cleansing, remineralizing and reducing plaque build-up on human teeth. The compositions are produced from naturally-derived naturally-processed, GRAS ingredients and have good remineralizing and plaque-reduction properties.
2. Description of the Related Art
Oral care compositions have progressed and created a large chemical industry devoted to developing new synthetic compounds to achieve ever improving tooth health for the consumer.
Tooth hypersensitivity is a common problem which affects about tens of millions of adults in the United States. It is estimated that close to 20% of adults in the U.S. have at least one or more sensitive teeth. Hypersensitive teeth may be sensitive to cold, heat, air or sugary foods.
The incidence of tooth hypersensitivity increases with age. Tooth hypersensitivity is believed to be related to the general increase in exposed root surfaces of teeth as a result of periodontal disease, tooth brush abrasion, or cyclic loading fatigue of the thin enamel near the dento-enamel junction. When root surfaces are exposed, dentinal tubules are also exposed. Dentinal tubules are naturally present in the dentinal layer of the tooth and they provide for an osmotic flow between the inner pulp region of the tooth and the outer root surfaces.
It is well established that tooth decay, development of plaque, plaque build-up, gingivitis, periodontal disease and other conditions of the oral cavity are associated with pathogens such as Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Actinomyces naeslundii, and/or Streptococcus mutans, among many others. For most individuals, proper oral care, including brushing with a standard, commercial dentifrice (such as a toothbrush) and appropriate toothbrushing along with the use of dental floss daily will maintain proper oral health. Even with proper oral health care, a significant number of persons suffer from tooth decay, plaque build-up and gingivitis that can lead to serious oral health issues.
It is estimated that over 150,000,000 cavities are filled in the United States every year at a cost of over $11 billion, and that over 20% of the adult population suffers from some form of gingivitis, from mild inflammation to severe gingival bleeding.
Gingivitis is a first form of periodontal disease typically caused by the long-term effects of plaque deposits. Plaque is the sticky, colorless, film material that develops on the exposed portions of the teeth. Unremoved plaque mineralizes into a hard deposit called calculus or tartar that becomes trapped at the base of the tooth. Plaque and calculus cause mechanical irritation and inflammation while bacteria in plaque cause the gums to become infected, swollen and tender. Other causes of gingivitis may include overly vigorous brushing or flossing the teeth or other injury or trauma to the gums. The conditions and problems stemming from plaque, plaque build-up and gingivitis may eventually lead to tooth loss, and a general degradation in a patient's overall health.
Human tooth enamel naturally undergoes a process of demineralization. Exposure of enamel to saliva and food slowly leaches minerals from teeth and eventually leads to increased susceptibility to decay. This process of demineralization results in incipient caries which are typically very small defects in the enamel surface that are typically left untreated. Carious dentin demineralization also may occur in patients that have exposed regions of dentin resulting from decay below the cementum-enamel junction.
Demineralization eventually leads to cavitation of enamel coating such that there is exposure of the underlying tooth structure. Typically, this type of decay is treated by drilling out the decayed region and inserting a semi-permanent filling material. However, a less invasive means of arresting and reversing decay is desired.
There are currently numerous synthetic chemicals used in oral care products intended to treat or prevent tooth hypersensitivity, tooth decay, plaque build-up, gingivitis, periodontal disease and tooth demineralization. Although these synthetic chemicals may be effective, consumers desire more natural products to treat and prevent oral health issues, such as those stated above.
Current toothpastes have abrasives, fluorides, strong flavors to hide the unpleasant taste of some ingredients, thickeners to allow the toothpaste to stay on the toothbrush, detergents/surfactants to clean dirt off the teeth, and non-nutritive sweeteners so bacteria growth is not encouraged.
Many oral care formulations commonly contain personal care synthetic ingredients which include: colorants such as synthetic dyes; surfactants such as sodium lauryl sulfate (SLS); emulsion stabilizing agents and thickeners such as carbomers (synthetic polymers of acrylic acid); artificial sweeteners such as acesulfame, saccharine and aspartame; and artificial flavors.
In addition to numerous personal care synthetic ingredients, many oral care formulations may have natural ingredients that are synthetically-derived or processed. Processes such as ethoxylation, sulfination or polymerization have the potential to change the chemical make-up of ingredients that start out natural, but may not remain so after processing. These types of processes dilute or change the composition of an ingredient and can involve caustic solvents, impurities and leave residual compounds behind. Natural, ecological processes such as distillation, condensation, extraction, steamed distillation, pressure cooking and hydrolysis are desirable to maximize the purity of natural ingredients.
Because of a desire to use renewable resources and to eliminate contact with potentially harmful synthetic materials, natural-based oral care compositions are gaining increasing interest. Most of these oral care compositions contain only some natural ingredients with the majority of their components being synthetic. One difficulty in formulating all-natural oral care compositions is achieving acceptable consumer performance with a limited number of raw materials. The number of all-natural ingredients available is scarce when compared to the number of highly developed synthetic surfactants, emulsifiers, colorants and other synthetic ingredients. Furthermore, since natural ingredients are naturally derived from nature, the chemical makeup and stability is not contstant and can make formulating large batches, during different seasons, very challenging.
A particulate bioactive glass, calcium sodium phosphosilicate, was developed by NovaMin Technology, Inc (hereinafter “NovaMin® bioactive glass”) and is used in dental care products. U.S. Pat. No. 5,735,942 describes NovaMin® bioactive glass in detail and is hereby incorporated by reference in its entirety. In aqueous solutions, NovaMin® bioactive glass comprises 45% SiO2, 24.5% Na2O, 24.5% CaO and 6% P2O5. NovaMin® bioactive glass delivers an ionic form of calcium, phosphorus, silica, and sodium which are necessary for bone and tooth mineralization. When microscopic particles of calcium sodium phosphosilicate are exposed to water, they release mineral ions that become available for the natural remineralization process. The ions form hydroxyapatite crystals, a form of hard and strong mineral in teeth. Calcium sodium phosphosilicate can be used as an effective, non-toxic alternative to fluoride or can be used in conjunction with fluoride.
Although manmade, calcium sodium phosphosilicate is a material that will form a layer of hydroxycarbonate apatite in vitro when placed in a simulated body fluid. NovaMin® bioactive glass is considered a class A bioactive material which will bond to both hard and soft tissue, so it provides an efficacious material for interaction with the tooth structure and does not trigger an overwhelmingly adverse immune response.
Prior art oral care and toothpaste compositions do not combine effective cleansing, demineralizing and plaque build-up reduction properties using almost exclusively naturally-derived, naturally-processed, GRAS (generally regarded as safe) ingredients. Prior art oral care and toothpaste compositions do not have at least 90% of the components of the product originating from renewable sources found in nature. Moreover, prior art oral care and toothpaste compositions do not have at least 90% of the components derived from natural, ecological processes. It is therefore an object of the present invention to provide an oral care and toothpaste composition that overcomes the disadvantages and shortcomings associated with those of the prior art.